Twirla® (levonorgestrel and ethinyl estradiol) transdermal system (Agile Therapeutics) is now available as a method of contraception for use in women of reproductive potential with a body mass index (BMI) <30kg/m2 for whom a combined hormonal contraceptive is appropriate.
The transdermal system delivers 120mcg of levonorgestrel and 30mcg of ethinyl estradiol per day and is applied once every 7 days for 3 consecutive weeks followed by 1 week without a patch, when withdrawal bleeding is expected. The patch, which is less than 1mm thin, can be applied to the abdomen, buttock or upper torso (excluding breasts).
Twirla is contraindicated in women with a BMI ≥30kg/m2, while the effectiveness of the product may be reduced in women with a BMI ≥25 to <30kg/m2. A summary of efficacy results from an open-label, single-arm trial (N=2031) showed that the overall Pearl Index (PI) in the primary efficacy population (18-35 years old [n=1736]; mean BMI: 28.3kg/m2) was 5.8 (95% CI, 4.5-7.2). Study findings also demonstrated a difference in efficacy based on BMI subgroup analysis:
- BMI <25kg/m2: PI was 3.5 (95% CI, 1.8-5.2) based on 6007 evaluable cycles
- BMI ≥25 and <30kg/m2: PI was 5.7 (95% CI, 3.0-8.4) based on 3881 evaluable cycles
- BMI ≥30kg/m2: PI was 8.6 (95% CI, 5.8-11.5) based on 5264 evaluable cycles.
With regard to safety, the most common adverse reactions reported in Twirla users were application site disorders, nausea, headache, dysmenorrhea, and increased weight. Like with other combined hormonal contraceptives, the use of Twirla may increase the risk for a venous thromboembolic event (VTE). In the phase 3 study, 4 Twirla-treated women experienced a VTE; all of these women had a BMI >30kg/m2.
Coinciding with the launch, the Company has introduced a patient resource program called The Loop. Through this initiative, patients can request a replacement patch as well as ask qualified nurse educators about patch use.
Twirla is supplied as a carton of 3 identical transdermal systems and as a single transdermal system for replacement as needed.
For more information visit twirla.com.